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Restrictions on dispensing DHEA

March 19, 2013

The college has had several questions recently about dispensing DHEA. Dehydroepiandrosterone, also known as androstenolone or prasterone, as well as 3β-hydroxyandrost-5-en-17-one or 5-androsten-3β-ol-17-one, is an endogenous steroid hormone.

DHEA is a Schedule 1 (prescription only) drug. (It is found under the name prasterone on the National Drug Schedule). It is also a controlled substance.

Therefore, prescriptions may be written or verbal, but may only be refilled if the prescriber has authorized the number of times and the dates for, or intervals between, refills. Transfers are not permitted. See ACP Prescription Regulations 2012 for additional information.

Since this drug is a controlled substance, pharmacists may not prescribe DHEA (either as an initial prescription or by adapting a prescription).

Warning: Pradaxa® must be dispensed in original packaging

Pradaxa® (dabigatran etexilate) is only available in Canada from the manufacturer in foil blister packaging.†

This product must be stored in this original packaging to protect it from moisture and light.
To ensure appropriate drug bioavailability, the entire capsule should be swallowed whole/intact, never chewed, nor opened.
To ensure the integrity of the capsule, the foil should always be peeled open so that the capsule is not pushed through the foil.

Given this, Pradaxa® must be dispensed in its original packaging.

As individual capsules are large and sealed within foil, placement of these units in a dosette or pill organizer is only recommended when the original packaging is maintained. Should your pharmacy not have compliance packaging with large enough pockets to enable product placement within its original packaging, Pradaxa® should not be dispensed for patients reliant on compliance packaging. In such cases, other oral anticoagulant options should be sought.

†Bottles of dabigatran are not available in Canada. Once a bottle is opened, it must be used within 4 months, and must be kept in the original bottle, sealed tightly.

Sources:

Stollberger C and Finsterer J.  Concerns about storage and application of dabigatran and rivaroxaban.  Eur J Clin Pharmacol DOI 10.007/s00228-012-1366-7.  Published online August 2, 2012.
Pradaxa® Production Monograph, Boehringer Ingelheim Canada Ltd., Burlington, Toronto.  Revision December 24, 2012. 
Submitted on behalf of the Anticoagulation Management Service, University of Alberta Hospital, Edmonton.


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